Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000826044
Ethics application status
Approved
Date submitted
27/09/2010
Date registered
1/10/2010
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
'XGAMBLE'- The effect of counselling on gambling behaviours in four New Zealand population groups
Scientific title
'XGAMBLE'- A pragmatic multi-centred randomised trial in New Zealand (NZ) investigating improvement in gambling behaviours amongst four different ethnic population groups who received counselling delivered by telephone versus delivered face-to- face
Secondary ID [1] 252805 0
None
Universal Trial Number (UTN)
None
Trial acronym
XGAMBLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adults who were screened and they met the Diagnostic Statistical Manual-version IV (DSM-IV), Text Revision criteria- probable pathological gambling and/or pathological gambling 258272 0
Condition category
Condition code
Mental Health 258463 258463 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Counselling provided face-to-face (on one-to-one basisi)

Participants of ALL ethnicities were recruited from four specific locations- Auckland, Hawkes Bay, Nelson, and Christchurch where participants could receive either face-to-face or telephone interventions by the participating practitioners.

Each practitioner was a currently practicing clinician within a Ministry funded problem gambling service, with the relevant training and years of experiences in working with individuals affected by problem gambling and their significant others. In other words, they were competent practitioners that provided support and treatment for the clients that presented to this trial.

The study was described as “XGAMBLE” to all participants, who were aware that different groups would have different intervention modalities made available to them.

Participants commenced interventions from one of the two treatment arms: face-to-face and telephone. The primary intervention model or intervention procedures adopted in this trial were informed by the Intervention Manual (citation: Manual Writing Group. (2006). Manual of procedures: Problem gambling intervention studies. Auckland: Centre for Gambling Studies, University of Auckland, please contact Tse for details, [email protected]). All of the services provided were free, strictly confidential and delivered in a professional manner.

The writing of the manual was contributed to jointly, by a group of senior practitioners working in the field of problem gambling interventions. They were invited to join the group on the basis of: 1) practitioners’ experiences in the sector, 2) experiences in writing intervention manuals or protocols within their own organisation or professional groups; and, 3) expertise and insights in working with specific population groups. A two-day workshop was held at the School of Population Health at Tamaki Campus, University of Auckland on 17th and 18th July 2006.

The Manual includes helpful hints for problem gambling counselling and a list of common interventions used by most gambling practitioners (see below). Not every practitioner would use the same interventions for each client.

Referring on
Tikanga protocols (i.e. Maori customs and traditions)
Budget advice
Cognitive distortions/thinking errors
Desensitization
Bans and self-exclusions
High-risk situations
Early warning signs
Developing safety plan
Use of significant others
Relationship counselling
Stress release
Lifestyle balance
Gambling education
Insight/Awareness-raising
Normalizing/validating
Instilling hope
Feeling identification
Positive feedback
Goal-setting
Review of progress
Review of resources
Coaching/Role-plays
Didactic interventions

Face-to-face and Telephone services
Intervention services were provided according to the Interventions Manual which outlined the assessments, major intervention approaches and activities/tasks to be performed by practitioners. These were identical for both face-to-face and telephone interventions.

There was no restriction on the frequency or duration of counselling sessions - that is, this trial evaluated the delivery of intervention services in a naturalistic setting. Similarly, if they were deemed to be appropriate, the services could offer any culturally-specific interventions.

The intensive part of the intervention lasted up to six sessions; intervention period could spread up to 3 months. Practitioners were asked to complete a form documenting the major elements and/or activities of the services provided for each client involved in this study. 'End of the intervention' was operationally defined as when clients completed their planned treatment, OR failed to attend 2 or more consecutive sessions, OR when clients advised that they no longer wish to continue.

The evaluation of intervention integrity was performed by a multi-disciplinary team comprising of experts on the two problem gambling treatment modalities and experienced researchers, including those from relevant ethnic backgrounds. The monitoring and evaluation process took place in the following steps:
* Definition: The major treatment models that are utilised in intervention services were defined (i.e. written in the Intervention Manual).
* Formative evaluations: These were also conducted on the experiences of participants (in terms of both clients and practitioners).
* Evaluation: Evaluative stages also included documentation and feedback from the participating practitioners upon the termination of intervention. Examples of information collected from the practitioners included:
1. Any reasons for termination (e.g. as planned, failure to attend, or “I am OK now”).
2. A brief summary of what was covered over the course of the intervention.
3. Outcomes achieved.
4. Evaluation of efficacy of interventions:
a. In respect to the goals set, which have been achieved?
b. What was most helpful about the intervention?
c. What did not work?
Intervention code [1] 257287 0
Lifestyle
Intervention code [2] 257290 0
Behaviour
Intervention code [3] 257291 0
Treatment: Other
Comparator / control treatment
Counselling provided on phone (comparison on service delivery format)

Intervention services were provided according to the Interventions Manual which outlined the assessments, major intervention approaches and activities/tasks to be performed by practitioners. The general contents were identical for both face-to-face and telephone interventions. We did not direct the number, frequency or duration of sessions; the counsellors would determine as what they would normally do in their real, pragmatic practice.
Control group
Active

Outcomes
Primary outcome [1] 259299 0
Total money spent on gambling over the last four weeks
Timepoint [1] 259299 0
Were measured repeatedly at baseline, post-intervention and end of 6-week follow up, by asking the participants to recall the money they had spent over this period by a phone interview
Primary outcome [2] 259302 0
Total time spent on gambling over the last four weeks
Timepoint [2] 259302 0
Were measured repeatedly at baseline, post-intervention and end of 6-week follow up, by asking the participants to recall the time they had spent over this period by a phone interview
Secondary outcome [1] 265732 0
Participants' attitude towards gambling activities
Timepoint [1] 265732 0
were measured repeatedly at baseline, post-intervention and end of 6-week follow up, by using the Gambling Attitudes and Beliefs Survey (GABS)
Secondary outcome [2] 265733 0
Participants' motivation/ readiness to change their gambling behaviours
Timepoint [2] 265733 0
were measured repeatedly at baseline, post-intervention and end of 6-week follow up, by using the Gambling Readiness to Change Questionnaire (GRTC)

Eligibility
Key inclusion criteria
1. They were aged 16 years or above;
2. They were currently experiencing problem gambling (as measured by DSM-IV: a score of 3 or more);
3. They were residing in one of the locations - Auckland, Hawkes Bay, Nelson, and Christchurch, where face-to-face interventions were available;
4. There was an appropriate practitioner available (choice of culture/gender);
5. They were able to attend face-to-face intervention sessions and receive telephone calls;
6. Their primary problem mode was pokie machines; and,
7. They provided informed consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. They were at immediate risk of harm to self or others;
2. They were not interested in participating in the research process (refused consent);
3. They were not able to commit to face-to-face or telephone counselling services;
4. They were ‘sensitive cases’ - such as individuals who were involved in a court case against the gambling industry or treatment agencies; and,
5. They refused random allocation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation:
1. Randomisation was achieved through a Central Telephone Service (research call centre) via a web-based computer system.
2. The telephone service was staffed by research staff/associates, not practitioners.
3. Consenting participants were randomly assigned to one of the two intervention arms, stratified by practitioners.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used to generate the random allocation sequence was computer-based and called ‘stratified minimisation'. Randomisation was stratified by practitioners to ensure that roughly equal numbers of participants allocated to each practitioner were randomised to each of the two intervention arms. The distribution between groups was similar.

Schedule of intervention and measures
1. Informed consent was requested following an introduction to the research and ascertaining that the potential participant had met ‘participant eligibility’.
2. Demographic and baseline data were collected.
3. Random allocation of the participant to one of the two groups (face-to-face or telephone modality). All the participating practitioners, in both modalities, are qualified practitioners recruited from the Ministry funded problem gambling services. They have undergone training in the use of Intervention Manual for the present trial to make sure the practitioners are competent to provide the interventions in either face-to-face or telephone modality.
4. Allocation of the participant to the appropriate service and notification of the practitioner.
5. The practitioner contacted the participant and commenced the intervention. The intervention was considered completed for the purpose of the present trial after six sessions (as suggested by the participating practitioners). For those clients who required more than six sessions, they continued to receive intervention services, and the post-evaluation form was filled in by the responsible practitioner.
6. Following termination of the intervention, the Project Team were notified by the practitioner.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blinding
1. Double-blinding was not possible in this design.
2. Assessor blinding relied on participants not disclosing which group they had been allocated/referred to.
3. Data was collected by researchers, not the practitioners that provided the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment outside Australia
Country [1] 2923 0
New Zealand
State/province [1] 2923 0

Funding & Sponsors
Funding source category [1] 257725 0
Government body
Name [1] 257725 0
Ministry of Health, New Zealand
Country [1] 257725 0
New Zealand
Primary sponsor type
Government body
Name
Ministry of Health, New Zealand
Address
Postal: PO Box 5013. Wellington 6145, New Zealand

Street Address: Ministry of Health Level 2, No 1 The Terrace Wellington 6011, New Zealand
Country
New Zealand
Secondary sponsor category [1] 256941 0
None
Name [1] 256941 0
Address [1] 256941 0
Country [1] 256941 0
Other collaborator category [1] 251532 0
University
Name [1] 251532 0
Clinical Trial Research Unit, CTRU, at University of Auckland
Address [1] 251532 0
Street Address: 261Morrin Road, Glen Innes, Tamaki Campus, School of Population Health, Auckland, New Zealand

Postal Address: School of Population Health, Tamaki Campus, The University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand
Country [1] 251532 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259776 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 259776 0
Ethics committee country [1] 259776 0
New Zealand
Date submitted for ethics approval [1] 259776 0
13/05/2006
Approval date [1] 259776 0
13/07/2006
Ethics approval number [1] 259776 0
The University of Auckland Human Ethics Committee approved the ethics application (Ref: 2006/203)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31664 0
Address 31664 0
Country 31664 0
Phone 31664 0
Fax 31664 0
Email 31664 0
Contact person for public queries
Name 14911 0
Dr Samson Tse
Address 14911 0
Department of Social Work & Social Administration
Faculty of Social Sciences
The University of Hong Kong

Postal Address: Pokfulam Road, Hong Kong, China
Physical Address: 13/F, K.K. Leung Building, Room 1326
Country 14911 0
Hong Kong
Phone 14911 0
00852 2859 1071
Fax 14911 0
00852 2858 7064
Email 14911 0
[email protected]
Contact person for scientific queries
Name 5839 0
Dr Samson Tse
Address 5839 0
Department of Social Work & Social Administration
Faculty of Social Sciences
The University of Hong Kong

Postal Address: Pokfulam Road, Hong Kong, China
Physical Address: 13/F, K.K. Leung Building, Room 1326
Country 5839 0
Hong Kong
Phone 5839 0
00852 2859 1071
Fax 5839 0
Email 5839 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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